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FDF Dossiers
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ABOUT THIS PAGE
A Calcium Ion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Ion, including repackagers and relabelers. The FDA regulates Calcium Ion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Ion API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Calcium Ion supplier is an individual or a company that provides Calcium Ion active pharmaceutical ingredient (API) or Calcium Ion finished formulations upon request. The Calcium Ion suppliers may include Calcium Ion API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Ion suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Calcium Ion Drug Master File in Japan (Calcium Ion JDMF) empowers Calcium Ion API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Calcium Ion JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Ion JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Calcium Ion suppliers with JDMF on PharmaCompass.
Calcium Ion Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Calcium Ion GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Calcium Ion GMP manufacturer or Calcium Ion GMP API supplier for your needs.
A Calcium Ion CoA (Certificate of Analysis) is a formal document that attests to Calcium Ion's compliance with Calcium Ion specifications and serves as a tool for batch-level quality control.
Calcium Ion CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Ion CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Calcium Ion may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Ion EP), Calcium Ion JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Ion USP).
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